Device Classification Name |
System, Test, Blood Glucose, Over The Counter
|
510(k) Number |
K082486 |
Device Name |
GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE |
Applicant |
BAYER HEALTHCARE, LLC |
430 SOUTH BEIGER ST. |
MISHAWAKA,
IN
46544
|
|
Applicant Contact |
ROGER SONNENBURG |
Correspondent |
BAYER HEALTHCARE, LLC |
430 SOUTH BEIGER ST. |
MISHAWAKA,
IN
46544
|
|
Correspondent Contact |
ROGER SONNENBURG |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/28/2008 |
Decision Date | 10/08/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|